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China NMPA Newsletter
NMPA New Approvals in November 2023
In November 2023, NMPA approved 301 medical devices, including 34 Class III
imported products, 39 Class II imported products, and 226 Class III domestic
products.
Below is a list of approved Class III and Class II imported products in November
2023.
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Medical Device/IVD |
Manufacturer |
Category |
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Proton Therapy System |
Varian Medical Systems Particle Therapy GmbH & Co. KG |
Class III |
|
Amplatzer Talisman PFO Occluder |
Abbott Medical |
Class III |
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Amplatzer Talisman Delivery Sheath |
Abbott Medical |
Class III |
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CONTACT LENSES |
Supervision Optimax Sdn Bhd |
Class III |
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Arctic Sperm Cryopreservation Medium |
FUJIFILM Irvine Scientific， Inc. |
Class III |
|
Anchored balloon dilatation catheter |
株式会社カネカ |
Class III |
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Dual-curing bonding resin watermend |
Tokuyama Dental Corporation |
Class III |
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SU-POR Patient-Specific Surgical Implant |
Poriferous， LLC |
Class III |
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Sterile Silicone Breast Implants Motiva Implant Matrix |
Establishment Labs S.A. |
Class III |
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ProTi360°Interbody System |
Tyber Medical， LLC |
Class III |
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MP Monoblock Hip Prosthesis Stem |
Waldemar Link GmbH & Co. KG |
Class III |
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NMPA Upgrades Regulatory Classification of Degradable
Expandable Hemostatic Sponge Products
NMPA released information on December 4th to upgrade the
classification of Degradable Expandable Hemostatic Sponge
Products from Class II to Class III.
In an effort to clarify the management attributes and categories
of Degradable Expandable Hemostatic Sponge products, the
National Medical Products Administration has released a notice
outlining key considerations. The following details are now
officially communicated:
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China and Denmark Strengthen Comprehensive Strategic
Partnership with “Green Joint Action Plan”
Background:Recognizing the mutual benefits of collaboration on
bilateral, multilateral, and global issues, the People’s
Republic of China and the Kingdom of Denmark established a
comprehensive strategic partnership in 2008. Underlining their
commitment, both nations formulated the “China-Denmark Joint
Action Plan (2017-2020)” in 2017. In November 2021, the foreign
ministers of China and Denmark agreed on the “China-Denmark
Green Joint Action Plan,” further solidifying bilateral
cooperation within the framework of their comprehensive
strategic partnership.
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China NMPA Reports 6 Cases of Illegal Online Sales of
Medical Devices
On December 5th , the National Medical Products Administration
(NMPA) has guided local drug regulatory authorities to intensify
monitoring and crack down on illegal activities through the
National Medical Device Online Sales Monitoring Platform. This
initiative aims to protect public health and ensure the safety
of medical equipment.
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Featured News-Medical Aesthetics |
China
National Medical Products Administration Clarifies Management Category
for Biodegradable Hemostatic Sponges
On December 6, 2023, China National Medical Products Administration’s
Comprehensive Department outlined the categorization of Biodegradable Hemostatic
Sponges, specifying a shift from Class II to Class III in the management
hierarchy.
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